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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

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UPDATED
Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
B. Braun reports PIL errors in Meropenem 1000 mg infusion product
B. Braun Melsungen AG has informed the MHRA of patient information leaflet errors in certain Meropenem 1000 mg powder and solvent batches.
UPDATED
Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
MHRA Field Safety Notices Issued 14‑18 September 2026
MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.
UPDATED
Regulatorische Updates
17. Sept. 2026•1 Min. Lesezeit
MHRA Review Highlights RF Safety Issues in Wireless CTG Monitors
The MHRA identified signal crossover, erroneous traces and dropouts in wireless cardiotocography systems that use radio‑frequency telemetry.
UPDATED
Regulatorische Updates
17. Sept. 2026•1 Min. Lesezeit
MHRA notified of barcode error in Martindale Clobazam oral suspension batches
Martindale Pharmaceuticals reported a linear barcode error affecting certain batches of Clobazam 5 mg/5 mL and 10 mg/5 mL oral suspension (150 mL) to the MHRA.
UPDATED
Regulatorische Updates
16. Sept. 2026•1 Min. Lesezeit
MHRA Alert: Patient Hoists and Slings Pose Fatal Fall Risk
MHRA reports ongoing fatal and serious harm from patient falls involving hoists or slings, noting an average of two deaths in recent incidents.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
MHRA Field Safety Notices Published 7‑11 Sep 2026
MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.
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UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
MHRA withdraws UK marketing authorisation for Tavneos (avacopan)
The UK MHRA has decided to withdraw the marketing authorisation for Tavneos (avacopan) for ANCA-associated vasculitis, halting new patient supply from 1 Sept.
UPDATED
Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
MHRA Issues Multiple Field Safety Notices (31 Aug – 4 Sep 2026)
MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.
UPDATED
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
MHRA publishes field safety notices for medical devices (24‑28 Aug 2026)
The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.
UPDATED
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
MHRA alerts: Use filters for parenteral nutrition to prevent fatal embolism
The MHRA reports that delivering parenteral nutrition without a filter has caused adverse incidents, including a fatal embolism, urging filter use in all care settings.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
MHRA Safety Roundup – Latest Advice for Medicines and Devices
A brief summary of the MHRA’s latest safety advice for medicines and medical device users.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
MHRA Announces Ninth Annual MedSafety Week, 4‑10 November 2024
The MHRA's ninth MedSafety Week runs 4‑10 November 2024, encouraging public reporting of medication safety issues.